BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)

    MDR report key: 20726716 · Received November 19, 2024

    Report

    Report Number
    3003306248-2024-07161
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 30, 2024
    Report Date
    January 17, 2025
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    UDI-DI
    07640135140689
    PMA / PMN Number
    K131179
    Removal / Correction Number
    FA-Q224-HF-2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF THE CENTRIMAG CONSOLE NOT PASSING SURGE TESTING WAS CONFIRMED VIA THE CONSOLE¿S FUNCTIONAL ANALYSIS. THE RETURNED CENTRIMAG CONSOLE (SERIAL NUMBER (B)(6) WAS RECEIVED AT THE EUROPEAN DISTRIBUTION CENTER (EDC), AND THE CONSOLE DID NOT PASS ITS 1KV AND 2KV SURGE COUPLING TESTS. THE UNIT WILL BE HELD BY THE EDC UNTIL PARTS BECOME AVAILABLE FOR REWORK. THE ROOT CAUSE FOR THE REPORTED EVENT WAS DETERMINED TO BE RELATED TO THE AC/DC POWER SUPPLY. A CORRECTIVE ACTION WAS INITIATED FOR THIS ISSUE, AND THIS CENTRIMAG CONSOLE WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF THIS CORRECTIVE ACTION. REVIEW OF THE DEVICE HISTORY RECORD FOR THE CENTRIMAG CONSOLE, SERIAL NUMBER (B)(6), SHOWED THE DEVICE WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. THE 2ND GENERATION CENTRIMAG SYSTEM OPERATING MANUAL PROVIDES INFORMATION REGARDING EMERGENCY/TROUBLESHOOTING IN SECTION 9. THE RECOMMENDED PRACTICE WHENEVER THERE IS A CONSOLE OR MOTOR MALFUNCTION IS TO REPLACE THE CONSOLE AND MOTOR AS A SET. REMOVE THE BLOOD PUMP FROM THE MALFUNCTIONING MOTOR AND CONSOLE AND PLACE THE BLOOD PUMP IN THE BACK-UP MOTOR AND CONSOLE. SWITCH ALL COMPONENTS (CONSOLE, MOTOR, FLOW PROBE AND CABLES) SIMULTANEOUSLY TO CONTINUE PATIENT SUPPORT, AND THEN PERFORM TROUBLESHOOTING ON THE NON-FUNCTIONING SYSTEM, WHEN IT IS NO LONGER BEING USED FOR PATIENT SUPPORT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE FAILED 1KV AND 2KV L-N SURGE COUPLING TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2069669 CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO) CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS DWA THORATEC SWITZERLAND GMBH 201-90401 7484995 07640135140689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown